Home NDC 0574-4135 LOTEPREDNOL ETABONATE
Product NDC 0574-4135
11-digit product format 005744135
Labeler code 0574
Product ID 0574-4135_1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name loteprednol etabonate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Padagis US LLC
Application ANDA215204
Marketing category ANDA
Marketing start 2026-01-12
Substance LOTEPREDNOL ETABONATE
Active strength 5 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215204-001 LOTEPREDNOL ETABONATE LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2025-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215204-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A215204-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2025-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215204-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2025-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215204-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2025-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215204-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2025-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215204-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2025-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215204-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2025-01-29 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215204-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2025-01-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base LOTEPREDNOL ETABONATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOTEPREDNOL ETABONATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YEH1EZ96K6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311382 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0574-4135-05 LOTEPREDNOL ETABONATE 1 in 1 CARTON SUSPENSION/ DROPS 1 2 0574-4135-05 LOTEPREDNOL ETABONATE 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 5 2 0574-4135-10 LOTEPREDNOL ETABONATE 1 in 1 CARTON SUSPENSION/ DROPS 1 2 0574-4135-10 LOTEPREDNOL ETABONATE 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 2 0574-4135-15 LOTEPREDNOL ETABONATE 1 in 1 CARTON SUSPENSION/ DROPS 1 2 0574-4135-15 LOTEPREDNOL ETABONATE 15 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 15 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0574-4135-05 00574413505 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-05) / 5 mL in 1 BOTTLE, DROPPER 2026-01-12 No No Current 0574-4135-10 00574413510 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-10) / 10 mL in 1 BOTTLE, DROPPER 2026-01-12 No No Current 0574-4135-15 00574413515 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-15) / 15 mL in 1 BOTTLE, DROPPER 2026-01-12 No No Current